Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device… — Class II medical device recall Z-0451-2016
Terminated recall by Shimadzu Medical Systems, reported 2015-12-30. The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server prope
| Recall number | Z-0451-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Shimadzu Medical Systems, Torrance, CA, United States |
| Recall initiated | 2015-11-10 |
| Classified | 2015-12-18 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2016-10-27 |
| Countries outside the US | CA |
| Quantity | 297 units |
| Serial numbers | 41DBBA131001, 41DBBA131002, 41DBBA131003, 41DBBA131004, 41DBBA131005, 41DBBA131006, 41DBBA131007, 41DBBA131008, 41DBBA131009, 41DBBA131010, 41DBBA131011, 41DBBA131012, 41DBBA131013, 41DBBA131014, 41DBBA131015, 41DBBA131016, 41DBBA131017, 41DBBA131018, 41DBBA131019, 41DBBA131020, 41DBBA132001, 41DBBA132002, 41DBBA132003, 41DBBA132004, 41DBBA132005 and 276 more |
Product
Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency.
Reason for recall
The firm is recalling the Shimadzu Mobile X-ray system because an image may not transfer to image server properly.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0451-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.